Albuterol/Budesonide Associated With Fewer Asthma Exacerbations

Patients with mild to moderate asthma treated with a fixed-dose combination of albuterol/budesonide have a decrease in asthma deteriorations and severe exacerbations at 12 weeks, according to study results of a phase 3 clinical trial presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2022 Annual Scientific Meeting, held from November 10 to 14, 2022.

Researchers recruited 989 patients and randomly assigned them to receive albuterol/budesonide 180/160 µg (n=197), albuterol/budesonide 180/80 µg (n=201), albuterol 180 µg (n=196), budesonide 160 µg (n=199), or placebo (n=196) 4 times daily for 12 weeks to study the effects of albuterol-budesonide on asthma deteriorations and severe exacerbations (DENALI; ClinicalTrials.gov Identifier: NCT03847896).

At baseline, patients were at least 12 years of age, had a forced expiratory volume in the first second of expiration (FEV₁) between 50% and 85%, and had a reversibility of at least 15%. Exploratory endpoints were asthma deterioration and severe exacerbations.

A greater percentage of patients who received albuterol 180 µg experienced at least 1 asthma deterioration (58.7%) compared with those who received albuterol/budesonide 180/160 µg (34.5%), albuterol/budesonide 180/80 µg (42.3%), budesonide 160 µg (47.7%), and placebo (53.6%). The mean [SD] number of days that patients experienced asthma deteriorations was 3.1 [7.1] in those who received albuterol/budesonide 180/160 µg, 4.5 [9.5] in those who received albuterol/budesonide 180/80 µg, 8.2 [12.9] in those who received albuterol 180 µg, 5.1 [12.0] in those who received budesonide 160 µg, and 8.1 [14.9] in those who received placebo.

Patients who received albuterol/budesonide 180/160 µg or albuterol/budesonide 180/80 µg experienced fewer severe exacerbations (2.0% and 2.5% vs 10.2% and 7.1%, respectively) compared with patients who received albuterol and placebo. Receipt of albuterol/budesonide 180/160 µg (22 days) was associated with fewer exacerbations compared with albuterol/budesonide 180/80 µg (31 days), albuterol 180 µg (130 days), budesonide 160 µg (42 days), and placebo (85 days).

The mean [SD] number of inhalations of rescue therapy per day was 1.27 [1.4] for participants who received albuterol/budesonide 180/160 µg, 1.43 [1.7] in those who received albuterol/budesonide 180/80 µg, 1.92 [2.0] in those who received albuterol, 1.40 [1.6] in those who received budesonide, and 1.94 [1.9] in those who received placebo.

“In this 12-week study in mild-to-moderate asthma, patients receiving albuterol-budesonide 4 times daily experienced numerically fewer asthma deteriorations and severe exacerbations than those receiving albuterol or placebo 4 times daily, and, at 180/160 µg, numerically fewer days with severe exacerbations vs budesonide,” the study authors concluded.